Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders

The specific aim of this project is to validate clinical tests to be used as outcome measures in studies of mTBI-related vision problems.

Study Overview

• Status: Recruiting
• Conditions: MTBI - Mild Traumatic Brain Injury

Detailed Description

Participants with (n=50) and without (n=100) a history of mTBI will be recruited. Investigators will study the use of a series of visual endurance tests (tests that require sustained visual responses over a period of time). In addition to developing expected values for these tests, investigators will also after qualitative data about discomfort levels during testing.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Katie Holmbeck, BS; Phone Number: 2157801429; Email: kh3482@drexel.edu
• Study Contact Backup: Name: Mitchell Scheiman, OD, PhD; Phone Number: 2157801427; Email: ms5758@drexel.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Recruiting
      • The Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

mTBI

Description

Inclusion Criteria:

• Diagnosis of mTBI within previous 1 to 6 months
• Distance visual acuity better than or equal to 20/25 in each eye
• Score >21 on Convergence Insufficiency Symptom Survey

Exclusion Criteria:

• Diagnosis of moderate or severe TBI; > 30-min loss of consciousness
• Not wearing required refractive error)
• Disease(s) known to affect oculomotor system (multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease)-Manifest strabismus or intraocular injury (evaluated at vision examination)
• Cognitive delays that may impact testing

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
control participants; no history of mTBI
mTBI group; history of mTBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with abnormal near point of convergence	The ability to converge the eyes. A near point rod will be used with a 20/30 column of letters. The target will be moved towards the participant slowly, and when diplopia occurs, this will be recorded as the NPC break. The target will then be moved away from the eyes until single vision is regained, and this will be recorded as the NPC recovery. The unit of measure is cm and the NPC will be measured 3 times, with 10 seconds in between each measure, and averaged for each participant.	Baseline and visit 2, which occurs 8 weeks after the baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with abnormal positive fusional vergence	Compensatory ability to overcome exophoria. A handheld prism bar will be used along with a vertical column of 20/30 letters. The prism will be placed before one eye, and the participant will be asked to maintain clear, single vision. Participants will then report when the target becomes blurred (blur), then double (diplopia), and finally return to single vision (recovery). The unit of measure is prism diopters, and it will be measured three times, with 10 seconds in between each measurement, and averaged for each participant.	Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal vergence facility	This is a measure of vergence velocity. Using a 12-base-out and 3-base-in prism, participants will be instructed to regain clear single vision as quickly as possible. The investigator will count the number of times this can be accomplished in one minut.e	Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal accommodative amplitude	A near point rod will be used along with a column of 20/30 letters. The test will be performed monocularly, first with the left eye covered, and then with the right eye covered. The target will slowly be moved towards the participant, and the participant will be instructed to report when the target becomes blurred. The amplitude of accommodation will be measured 3 times, with 10 seconds in between each measure	Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal accommodative facility	This test assesses the speed and endurance of accommodation. A column of 20/30 letter will be used along with a timer, and +2.00D and -2.00D lens flippers. The test will be performed monocularly. The +2.00D lens will be placed before the participant's eye, and the participant will be asked to clear the target as quickly as possible. Once the participant clears the target, the -2.00D lens will be placed before the eye, and the participant will be asked to report when the target becomes clear again. This will be repeated as many times as possible within one minute. The investigator will report how many times this occurs in one minute.	Baseline and visit 2, which occurs 8 weeks after the baseline visit

Collaborators and Investigators

• Sponsor: Salus University
• Investigators: Study Chair: Mitchell Scheiman, Pennsylvania College of Optometry at Drexel University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 29, 2028
• Study Completion (Estimated): September 29, 2028

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: mTBI; concussion; convergence insufficiency; vision therapy; vision rehabilitation; concussion-related vision disorders
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Eye Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Cranial Nerve Diseases; Brain Injuries; Brain Concussion; Ocular Motility Disorders
• Other Study ID Numbers: 2406010608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will only be shared with the study investigators. REDCap will be used for data collection.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No